Overview

This trial is active, not recruiting.

Conditions coronary artery disease, aortic valve disorder, heart failure, aortic valve stenosis, aortic valve insufficiency
Treatment implantation of cep magna ease model 3300tfx
Phase phase 4
Sponsor Edwards Lifesciences
Start date October 2007
End date December 2019
Trial size 225 participants
Trial identifier NCT01171625, 2007-08

Summary

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
implantation of cep magna ease model 3300tfx CEP Magna Ease MOdel 3300TFX
Heart Valve Surgery

Primary Outcomes

Measure
Long term safety performance will be evaluated by comparing the linearized yearly rates listed below to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance
time frame: Entire study period (8 yrs post implant)

Secondary Outcomes

Measure
Early rates, late linearized rates, and actuarial rates
time frame: Entire study period (8 yrs post implant)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Primary - Require replacement aortic valve - Signed informed consent Exclusion Criteria: - Primary - Active endocarditis (< 3 mths) - Abnormal Ca metabolism - Aneurismal aortic degenerative condition

Additional Information

Official title Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
Description This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant annually for a minimum of 8 years.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.